Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

NCT ID: NCT02121665

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-03-31

Brief Summary

Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.

Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic (Inersan) Arm

Inersan Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Group Type: EXPERIMENTAL

Probiotic (Inersan)

Intervention Type: DRUG

Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2

Placebo Arm

Placebo Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Interventions

Probiotic (Inersan)

Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2

Intervention Type: DRUG

Placebo

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject of both sexes
• Age group of 25-65 years
• Subjects with generalized moderate to severe chronic periodontitis
• Signed informed Consent

Exclusion Criteria

• Any known history of systemic diseases
• Patients already on anti-inflammatory drugs or antibiotics
• Patients allergic to any material used in the study
• Pregnant and lactating women
• Periodontal therapy in past 6 months
• Current smoker or smoker in the past

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Government Dental College and Hospital, India

OTHER_GOV

Sponsor Role: collaborator

CD Pharma India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rohan Sethi, BDS

Role: PRINCIPAL_INVESTIGATOR

Government Dental College & Hospital, Aurangabad

Locations

Department of Periodontics, Government Dental College & Hospital

Aurangabad, Maharashtra, India

Countries

India

Other Identifiers

PLOZ/PG/PERIO/2013

Identifier Type: -

Identifier Source: org_study_id